Brain Cancer, Cognitive Impairment
Conditions
Keywords
Brain Cancer, Brain Tumor, Cognitive Impairment, Neurobehavioral Impairment, Neuropsychological Rehabilitation
Brief summary
The aim of the present randomized-controlled study is to evaluate the feasibility, acceptability, and preliminary efficacy of a novel, context-sensitive neuropsychological rehabilitation intervention for brain cancer survivors.
Detailed description
Cognitive impairment is the most common late effect in brain cancer survivors, with profound negative effects on quality of life, work ability, and socioeconomic outcomes. Still, there is no gold standard approach to treating cognitive impairment in brain cancer survivors. Furthermore, there is a dearth of research on interventions to treat cognitive impairment in brain cancer survivors, and the relatively few studied interventions have proven limited effects. Arguably, four key elements are missing from a majority of studied interventions:1) transfer of learning to real-world functional outcomes, 2) awareness training to enhance compensatory strategy use, 3) inclusion of carers that could enhance transfer of learning to the home, and 4) recognition of the inter-related nature of cognitive, neurobehavioral, and psychological functions. The I'M aware: Patients and Carers Together (ImPACT) program is a novel, context-sensitive neuropsychological rehabilitation intervention that targets the above mentioned missing elements in previous rehabilitation efforts. The present feasibility randomized-controlled study aims to evaluate the feasibility, acceptability, and preliminary efficacy of this program in brain cancer survivors with cognitive impairment in preparation for a subsequent large-scale randomized controlled trial.
Interventions
BEHAVIORALImPACT program
During the ImPACT program, the brain cancer survivor and a carer collaborate on: 1. Becoming aware of the patient's core strengths and difficulties 2. Helping the patient to be optimally responsive to the guidance of the carer, and 3. Creating compensatory strategies to respond to real-world manifestations of the patient's difficulties and helping the patient implement these strategies at home.
Sponsors
University of Aarhus
Aarhus University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized waitlist controlled trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosis of brain cancer * Completed primary treatment at least 6 months ago * Medically stable * Speaks and understand Danish * Living with a carer aged 18 or over, who also speaks and understands Danish and consents to participate in the study alongside the patient
Exclusion criteria
• Confounding diagnosed or suspected psychiatric or medical condition unrelated to the cancer or its treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Carer-reported neurobehavioral functioning | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The carer-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment. |
| Self-reported cognitive functioning | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Patients Assessment of Own Functioning Inventory (PAOFI). 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment. |
| Carer-reported cognitive functioning | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Patients Assessment of Own Functioning Inventory (PAOFI) modified to informant version. 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment. |
| Self-reported neurobehavioral functioning | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The self-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carer-reported neurobehavioral functioning | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | The carer-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment. |
| Objective cognitive functioning (Neuropsychological tests; Patient only) | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | Global composite z-score based on the HVLT-R; Trail-making tests A and B; WAIS-IV Coding, Digit Span, Verbal Fluency; Conner's Continuous Performance Test III. |
| Premorbid intellectual functioning (Patient only) | Baseline (T1) | WAIS-IV Information subtest. 26 items; answer format range 0-1; total score range: 0-26. Higher score indicates higher premorbid intellectual functioning. |
| Self-reported fatigue | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue). 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue. |
| Carer-reported fatigue | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-Fatigue) modified to informant version. 13 items: answer format range 0-4; total score range: 0-52. Lower score indicates more fatigue. |
| Self-reported mental fatigue | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Mental Fatigue Scale (MFS). 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue. |
| Carer-reported mental fatigue | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Mental Fatigue Scale (MFS) modified to informant version. 15 items: answer format range 0-3; total score range: 0-45. Higher score indicates more mental fatigue. |
| Depression (patient only) | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Center for Epidemiologic Studies Depression Scale (CESD). 20 items: answer format range 0-3; total score range: 0-60. Higher score indicates more depression. |
| Carer-reported health-related quality of life | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Functional Assessment of Cancer Therapy-Brain (FACT-Br) modified to informant version. 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life. |
| Self-reported community integration | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The self-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration. |
| Carer-reported community integration | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The carer-report version of the Community Integration Questionnaire Revised (CIQ-R). 18 items: answer format range 0-2; total score range: 0-35. Higher score indicates more community integration. |
| Insomnia | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Insomnia Severity Index (ISI). 7 items; answer format range: 0-4; total score range: 0-28. Higher score indicates more insomnia. |
| Self-reported participant satisfaction | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction. |
| Carer-reported participant satisfaction | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Client Satisfaction Questionnaire (CSQ-8). 8 items: answer format range 1-4; total score range: 8-32. Higher score indicates better satisfaction. |
| Self-reported participant motivation | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation. |
| Carer-reported participant motivation | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The 7-item interest/enjoyment subscale of the Intrinsic Motivation Inventory (IMI). 7 items: answer format range 1-7; total score range: 1-7. Higher score indicates more motivation. |
| Self-reported health-related quality of life | Baseline (T1) to after last session (approximately 8 weeks later: Post-intervention, T3) | The Functional Assessment of Cancer Therapy-Brain (FACT-Br). 50 items; answer format range 0-4; total score range: 0-200. Higher score indicates better health-related quality of life. |
| Self-reported cognitive functioning | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | The Patients Assessment of Own Functioning Inventory (PAOFI). 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment. |
| Carer-reported cognitive functioning | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | The Patients Assessment of Own Functioning Inventory (PAOFI) modified to informant version. 33 items: answer format range 1-6; total score range: 0-33. Higher score indicates more impairment. |
| Self-reported neurobehavioral functioning | Baseline (T1) to 8 week after post-intervention (approximately 16 weeks later: Follow-up, T4)] | The self-report version of the Frontal Systems Behavior Scale (FrSBe). 46 items: answer format range 1-5; total score range: 46-230. Higher score indicates more impairment. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Qualitative Interviews | 8 weeks after post-intervention (approximately 16 weeks after Baseline assessment (T1): Follow-up, T4) | Following the T4 assessment, participants included in the intervention arm will be invited to participate in a 30-minutes semi-structured, audio recorded interview. |
Countries
Denmark
Outcome results
None listed